News highlights

A combination of medication and cognitive behavioral therapy (CBT) is the most effective treatment for adolescents with depression, according to a new report from the longest-running study of depressed teens.

The Treatment for Adolescents with Depression Study followed 327 patients at 13 sites who were between the ages of 12 and 17 and had been diagnosed with major depressive disorder. Patients were assigned to receive fluoxetine hydrochloride, CBT or a combination of the two, and their outcomes were followed for 36 weeks.

The study found that participants in the combination group had the highest response rate at 12 weeks, with 73% of the combination group responding, compared with 62% for fluoxetine and 48% for CBT. Combination treatment continued to be the most effective at 18 and 36 weeks, although the three groups were close to converging by the end of the study. By 36 weeks, more than 80% of participants in all groups were much improved.

The research also found that suicidal events were more common in patients receiving fluoxetine (14.7%) than in those getting the combination (8.4%) or CBT alone (6.3%), with most of the suicidal events occurring early in treatment. This finding indicates that CBT may protect against treatment-emergent suicidal events in patients taking fluoxetine, the study authors said. Based on the study results, they concluded that a combination of fluoxetine and CBT is superior to either treatment alone as a long-term treatment strategy for adolescents with depression.

The research was published in the October 2007 Archives of General Psychiatry and is online.

New long-term data indicate that seniors who get annual influenza and pneumonia vaccinations significantly reduce their risk of being hospitalized or dying during flu season.

The observational study, published in the Oct. 4 New England Journal of Medicine, analyzed data on vaccinations administered from 1990-91 through 1999-2000, including 713,872 person-seasons of observation. Vaccination was associated with a 27% reduction in the risk of hospitalization for pneumonia or influenza and a 48% reduction in the risk of death from any cause.

The consistency of the data over 10 flu seasons suggests that the protective effect of the vaccines is real and not due to confounding factors, such as a tendency for those who get vaccinations to be healthier or more compliant with medications, said an accompanying editorial. In addition, said the editorial, the protective effect varied according to how closely the vaccine matched the epidemic strain in a particular flu season.

The findings provide further support for continuing a strategy of vaccinating the elderly, said the editorial. The study also points to the need for developing safer and more effective vaccines, since about half of the hospitalizations and deaths in the study occurred among vaccinated adults. The editorial also called for improving the "appalling" low rate of vaccination among health care workers.

The FDA found no association between atrial fibrillation (AF) and the use of bisphosphonates, in contrast to findings reported last spring in the New England Journal of Medicine (NEJM).

An article and accompanying letter to the editor in the May 3 NEJM described increased rates of serious AF in two studies of older women with osteoporosis treated with zoledronic acid injection (Reclast) and alendronate sodium (Fosamax). In both studies, women taking one of the bisphosphonates developed a higher rate of AF than women on placebo, but the rates of AF between groups were not statistically significantly different.

However, the FDA reviewed spontaneous post-marketing reports of AF reported in association with bisphosphonate use and did not find an increased risk. In addition, the FDA's data review for the recent approval of once-yearly zoledronic acid injection for postmenopausal osteoporosis revealed that, in most cases, AF occurred more than a month after drug infusion. There was no significant difference in the prevalence of AF between patients who received zoledronic acid injection and those who received placebo in a subset of patients monitored by electrocardiogram up to 11 days following infusion.

Since AF is common in people age 65 and over--the age of many of the patients in the NEJM study--there are insufficient data to attribute an increase in AF to bisphosphonate use, said the FDA. Therefore, the agency advised physicians not to change their prescribing habits or use of bisphosphonates at this time.

The FDA's MedWatch Adverse Event Reporting program can be found online.

Hospital medicine

"Closed" ICUs can result in improved mortality in patients with acute lung injury, according to a new study.

Researchers at the University of Washington in Seattle used data from a cohort study to examine the relationship between ICU type--"closed" or "open"--and mortality rates in patients with acute lung injury. Closed ICUs were defined as those in which patients were cared for by an intensive care team or in which consultation with an intensivist was mandatory, while open ICUs were those in which any attending physician who had admission privileges could oversee care. The results appear in the Oct. 1 American Journal of Respiratory and Critical Care Medicine.

Twenty-four ICUs (13 closed, 11 open) were eligible for the study, and complete data were available for 23. Of 1,075 patients with acute lung injury admitted to the ICUs from April 1999 to July 2000, 684 (64%) received care in closed units and 391 (36%) received care in open units. Patients in closed units had lower mortality than those in open units, and pulmonary consultation in open units had no significant effect on mortality. A difference in mortality between ICU types persisted after adjustment for several variables, including illness severity.

The authors acknowledged that their sample was small and that results of observational studies are often subject to bias. However, they concluded that their results confirm those of previous before-after studies and provide further support for the closed ICU model in critically ill patients.

The American Journal of Respiratory and Critical Care Medicine is online.

Clinical news

Colonography and colonoscopy have similar detection rates for advanced colon growths, although polypectomies were fewer following screening and complications were considerably smaller in the colonography group, according to researchers at the University of Wisconsin Medical School.

Study authors suggested in the Oct. 4 New England Journal of Medicine that computed tomographic colonography (CTC) could be used as a primary screening test.

Researchers compared the diagnostic yield from parallel colonography and optical colonoscopy screening programs. They compared results from 3,120 consecutive patients enrolled in a colonography screening program during a 25-month period with those from 3,163 consecutive patients seen at colonoscopy screening during a 17-month period (with partially overlapping time periods). Exclusion criteria included polyp surveillance or a history of a bowel disorder.

Colonography and colonoscopy screening found 123 and 121 advanced neoplasms, including 14 and 4 invasive cancers, respectively. The referral rate for colonoscopy in the primary colonography screening group was 7.9% (246 of 3,120 patients). Advanced neoplasia was confirmed in 3.2% (100 of 3,120) of the colonography group and in 3.4% (107 of 3,163) in the colonoscopy group. There were also 158 patients with 193 unresected, colonography-detected polyps of 6 to 9 mm who were undergoing surveillance. There were seven colonic perforations in the colonoscopy group and none in the colonography group.

Researchers noted that patients chose which screening method to undergo, which precluded randomization. But key demographics, including age and gender, were comparable among the two groups. They concluded, "Primary colonography with selective colonoscopy also deserves consideration as a preferred screening strategy because it appears to achieve the same goals of detection and prevention but with the use of substantially fewer resources in terms of colonoscopy procedures and polypectomies."

Two new studies found that the effect of hormone therapy on overall cardiovascular disease risk (CVS) didn’t vary by age for postmenopausal women, though coronary heart disease risk rose with increasing number of years since menopause. Risk of stroke was elevated independent of years since menopause, however.

The research comprised two randomized, placebo-controlled trials from the Women’s Health Initiative undertaken at 40 U.S. clinical centers. Participants were 27,347 postmenopausal women age 50 to 79 years who were predominantly healthy. Women with a hysterectomy received either placebo or 0.625 mg of conjugated equine estrogen (CEE) per day, while women with an intact uterus received either placebo or 0.625 mg of CEE per day plus 2.5 mg of medroxyprogesterone acetate per day. They were followed up for a mean of 5.6 and 7.1 years, respectively.

Overall, the hormone therapy and placebo groups didn’t differ for coronary heart disease (CHD), total mortality and a global CVS index, but stroke risk was higher for the hormone group. The effect of hormone therapy didn’t vary by age or by years since menopause for most outcomes. However, CHD risk with hormone use rose as more time elapsed since menopause, and was elevated in women for whom more than 20 years had passed since menopause. The studies are abstracted in the September/October ACP Journal Club.

The results suggest that women younger than 60 years old who use hormone therapy for the first time during menopause, and for five years or less, aren’t at higher risk for heart attack, breast cancer or stroke, noted Journal Club reviewer Robert L. Reid, MD, of Queen’s University in Ontario. The medical community should return to the short-term use of hormone therapy to improve the quality of life in perimenopausal women with vasomotor symptoms, while older symptomatic women should be screened for heart risk factors and their hormone therapy should be considered on an individual basis, he said.

CMS news

The CMS last week announced a 3.1% increase in Medicare Part B premiums, the smallest percentage increase since 2001.

As of January, the Medicare Part B monthly premium will be $96.40, up from $93.50 in 2007. The Part B deductible will rise to $135, an increase of $4 over 2007.

CMS noted that a portion of the Part B premium increase is meant to raise the reserves in the Part B trust fund to a more adequate level. The reserves are needed to compensate if actual Part B expenditures are higher than anticipated. The current financing level is based on the assumption that Medicare would cut physician payments by 10% starting in January, according to the Oct. 2 New York Times. However, because CMS experts expect that Congress will intervene to prevent the scheduled cut, the program needs a larger reserve than would otherwise be necessary, agency officials said.

Women’s health

In recognition of National Breast Cancer Awareness Month, the CMS is asking physicians to help raise awareness about the importance of early detection and to let eligible patients know that Medicare covers screening mammograms and clinical breast exams.

Medicare provides coverage of an annual screening mammogram for all female beneficiaries age 40 and older and one baseline mammogram for female beneficiaries between the ages of 35 and 39. Clinical breast exams also are covered every 12 or 24 months, depending on risk level for the disease. According to CMS, many eligible women with Medicare do not take advantage of early detection at all and others do not get screening mammograms and clinical breast exams at regular intervals.

CMS asks physicians to "Pass the Word" about early detection of breast cancer by:

Helping patients understand their risk for breast cancer and the benefits of regular screening mammograms and clinical breast exams;

Encouraging patients to talk about any barriers that may keep them from obtaining mammography services on a routine basis and helping them overcome those barriers; and

Making sure that all eligible female patients are aware that Medicare covers mammography screenings every year and regular clinical breast exams.

Two recent studies found that women and blacks are less likely than men to receive implantable cardioverter defibrillators (ICDs) for the primary or secondary prevention of sudden cardiac death. However, the same studies also suggested that ICDs may not be benefiting the recipients as much as previously thought.

In the first study, researchers analyzed a sample of Medicare beneficiaries age 65 and older who were diagnosed with acute myocardial infarction and either heart failure or cardiomyopathy, with or without prior cardiac arrest or ventricular tachycardia. Among patients with prior myocardial infarction and either cardiomyopathy or heart failure, men were 2.4 times more likely than women to receive ICD therapy.

In a second observational study, researchers analyzed ICD use among 13,304 patients with heart failure and left ventricular ejection fraction of 30% or less treated between January 2005 and June 2007 at 217 hospitals. Among patients eligible for therapy, less than 40% received ICD therapy at discharge and rates of use were lower among women and blacks than among white men. Both studies were published in the Oct. 3, 2007 Journal of the American Medical Association (JAMA).

ICDs are recognized as potentially lifesaving therapy for those at high risk for sudden cardiac death, said an accompanying editorial. Medicare covers ICD use for primary prevention in all patients with New York Heart Association class II or III heart failure and left ventricular ejection fraction of less than 35%.

Perhaps even more troubling than the disparities in use, notes the editorial, is that those who received ICDs often did not fare better than those who received standard care. After controlling for comorbidities, researchers found that patients who received ICDs for primary prevention did not benefit in terms of all-cause mortality. The investigators also did not find a statistically significant quality-of-life benefit in patients who received ICDs.

Researchers noted that the apparent lack of benefit may be due to the fact that those who received ICDs were at higher risk. However, said the editorial, since the studies adjusted for age, comorbidity, year of cohort entry and probability of treatment, the findings lead to questions about whether women and minorities are receiving too few ICDs for primary prevention, or whether ICDs are being overused in (white) men.

Further research is needed on which Medicare beneficiaries are likely to benefit from ICD implementation for primary and secondary prevention, said the editorial. In order to answer that question, future research must focus not just on implantation rates, but also on clinical outcomes, such as survival and quality of life.

Women with certain risk factors may benefit from screening for abdominal aortic aneurysm (AAA), according to a large new study.

Researchers examined data from 10,012 women and 7,528 men across the U.S. who were screened for AAA from May 2004 to December 2006. Study participants underwent duplex ultrasonography and answered questionnaires about AAA risk factors. The researchers were specifically interested in determining the prevalence of and risk factors associated with AAA in women, since most studies to date have primarily involved men. The results appear in the October Journal of Vascular Surgery.

Screening detected 74 AAAs in women and 291 in men (prevalence, 0.7% and 3.9%, respectively). In women, older age, smoking history and cardiovascular disease were found to be independent risk factors for AAA and AAAs were more common in women with several atherosclerotic risk factors, with a prevalence of up to 6.4%.

The U.S. Preventive Services Task Force recently recommended against screening for AAA in women because research indicates that AAA is much less common in women than in men. The authors of this study, however, concluded that although overall prevalence rates in women are low, women with specific characteristics are at much higher risk and should be considered for screening.

Studies show that only 36% of all health care workers are immunized against influenza each year, and transmission of flu from health care workers to patients has been documented in nearly every health care setting. These statistics and others related to influenza’s impact on the population are addressed in a new recommendation released by ACP on the need for annual flu vaccinations for health care workers.

The recommendation calls for the annual influenza vaccination of all health care workers directly involved with patient care in the interest of improving the patient safety, employee safety, and decreasing the health care expenditures related to the illness. “Immunizing health care workers safely and effectively prevents a significant number of influenza infections, hospitalizations, and deaths among the patients they care for,” said Vincenza Snow, FACP, director of clinical programs and quality of care for ACP.

ACP joins major professional medical societies that have endorsed and published similar recommendations toward this effort. A full text of the ACP policy is online.

ACP’s Council of Young Physicians (CYP) is piloting a non-competitive patient safety/quality improvement poster showcase for young physician members attending Internal Medicine 2008, from May 15-17, in Washington, D.C.

The CYP invites young physician members to submit their abstracts in this category of research by Jan. 4, 2008. In order to be eligible to submit an abstract for the Internal Medicine 2008 Young Physician Patient Safety/Quality Improvement Poster Showcase, presenters must be post-training ACP Members or Fellows in good standing within 16 years of medical school graduation. The deadline for submissions for the showcase is Jan. 4, 2008.

For more information about the ACP Young Physician Patient Safety/Quality Improvement Poster Showcase, go online or contact ACP Membership Development at 800-523-1546, ext. 2666, or via e-mail at abstracts@acponline.org.

Test yourself

A 66-year-old man is evaluated for a persistent rash for 6 years' duration. The rash waxes and wanes in severity, and it becomes pruritic only after he becomes hot and sweating, such as when he mows the lawn or exercises. It has always been limited to his back and lower chest. He has never treated it. The patient is otherwise well, has no other medical problems, and takes no medication. Following a physical exam, what is the most likely diagnosis?

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